Business Wire - November 15, 2011
FOSTER CITY, Calif. - Gilead Sciences, Inc.
(Nasdaq: GILD) today announced that it has entered into a license
agreement with Tibotec Pharmaceuticals for the development and
commercialization of a single-tablet regimen combining Prezista(R)
(darunavir) with Gilead's Emtriva(R) (emtricitabine); its
investigational agent GS 7340, a novel prodrug of tenofovir; and
cobicistat, a pharmacoenhancer.
"We are pleased to once again be partnering with Tibotec to
advance and simplify HIV treatment for patients," said Norbert
Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. "This
is the first time we are developing a protease
inhibitor-containing single-tablet regimen, and we're able to do
that based on the small milligram size of GS 7340, which is less
than one tenth of the amount of the 300 mg of tenofovir
disoproxil fumarate contained in Viread and Truvada."
Gilead will be responsible for the formulation, manufacturing,
registration and, subject to regulatory approval, distribution
and commercialization of the single-tablet regimen worldwide.
Tibotec will have the right to co-detail the single-tablet
regimen in certain major markets.
Gilead first entered into a collaboration with Tibotec in July
2009 for the development and commercialization of a single-tablet
regimen combining Gilead's Truvada(R) (emtricitabine/tenofovir
disoproxil fumarate) and Tibotec's Edurant(R) (rilpivirine). The
product was approved under the trade name Complera(R)
(emtricitabine/rilpivirine/tenofovir disoproxil fumarate) in the
United States in August 2011.
On June 28, 2011, Gilead announced a licensing agreement with
Tibotec for the development of a fixed-dose combination
containing Prezista and cobicistat, which was contingent upon the
signing of the agreement to develop the Prezista, Emtriva, GS
7340 and cobicistat single-tablet regimen. Both agreements have
now been finalized. Subject to regulatory approval, Tibotec will
be responsible for the formulation, manufacturing, registration,
distribution and commercialization of the Prezista and cobicistat
fixed-dose combination worldwide.
Gilead is evaluating cobicistat in three separate pivotal Phase 3
studies, both as a stand-alone boosting agent for once-daily
atazanavir, as well as part of the all Gilead fixed-dose
single-tablet Quad regimen of elvitegravir, cobicistat and
Truvada for the treatment of HIV infection.
About GS 7340
GS 7340, Gilead's investigational anti-HIV agent, is a novel
prodrug of tenofovir, the active agent in the company's HIV drug
Viread(R) (tenofovir disoproxil fumarate). Phase 2a dose-ranging
studies have identified a dose that is ten times lower than
Viread and provides greater antiviral efficacy. Gilead expects to
initiate a Phase 2 study of GS 7340 early next year.
Cobicistat, GS 7340 and the Quad are investigational products and
their safety and efficacy have not yet been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company's mission is to advance the care
of patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations
in North America, Europe and Asia Pacific.
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors,
including risks related to whether ongoing clinical trials for
cobicistat and GS 7340 will be successful and Gilead's ability to
formulate cobicistat and GS 7340 with other agents, including
darunavir. In addition, safety and efficacy data from clinical
trials may not warrant further development of cobicistat, GS 7340
or the single-tablet regimen. Further, the regulatory authorities
may not approve cobicistat and GS 7340 as stand-alone products or
in any combination product, and marketing approval, if granted,
may have significant limitations on its use. As a result,
cobicistat, GS 7340 and the single-tablet regimen may never be
successfully commercialized. The parties may make a strategic
decision to discontinue development of the combination product
if, for example, Gilead is unable to successfully formulate the
single-tablet regimen or the market for the product fails to
materialize as expected. These risks, uncertainties and other
factors could cause actual results to differ materially from
those referred to in the forward-looking statements. These and
other risks are described in detail in Gilead's Quarterly Report
on Form 10-Q for the quarter ended September 30, 2011, as filed
with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update
any such forward-looking statements.
Complera, Emtriva, Truvada and Viread are registered trademarks
of Gilead Sciences, Inc.
Prezista and Edurant are registered trademarks of Tibotec, Inc.
For more information on Gilead Sciences, please visit the
company's website at www.gilead.com or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Rau, 650-522-5635 (Media)